A Randomized Controlled Clinical Trial of Treatment of Mild Gestational Diabetes with Glyburide versus Placebo
- Parkland Health & Hospital System
Brian Casey, M.D.
The aim of this study is to assess the impact of addition of Glyburlde to diet and nutritional counseling in women with gestational diabetes. This is a randomized, prospective, double-blinded, placebo-controlled, single center trial that will address the primary research question: Does addition of Glyburide treatment to nutritional counseling and diet therapy in women diagnosed with mild GDM significantly reduce infant birth weight by 200 grams as compared with standard treatment with diet alone. other outcome variables that this study will address include delivery of large for gestational age infants and/or macrosomia, frequency of neonatal intensive care unit admissions, maternal complications such as cesarean delivery and preeclampsia, and possible decrease in number of women with mild GDM who ultimately need to be treated with insulin.
after informed consent is obtained, patients will be randomized according to a predetermined randomization sequence prepared by Dr Mcintire, one of the investigators, to two treatment arms:
* Group i: Formal nutritional counseling and diet therapy, along with initiation on Glyburide
* Group ii: Formal nutritional counseling and diet therapy. along with initiation on placebo
* A glucose value of > 140mg/dl on a 50-gram oral glucose loading test by plasma at gestational age between 24 weeks 0 days and 27 weeks 6 days based on clinical information
* An Abnormal 3-hour oral glucose tolerance test with a fasting glucose of < 105mg/dl
* Gestational age of less than or equal to 30 weeks and 0 days at the time of consent/randomization
* Singleton gestation